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OMVClass II

Ultrasonic Body Composition Analyzer

21 CFR 870.2770 / Cardiovascular
FDA source (opens on fda.gov)

OMV is the FDA product code for Ultrasonic Body Composition Analyzer, a class II device type, regulated under 21 CFR 870.2770. FDA's definition for this code reads: "Intended to measure thickness of a distinctive tissue layer. Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OMV
Device name
Ultrasonic Body Composition Analyzer
FDA definition
Intended to measure thickness of a distinctive tissue layer. Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively.
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code OMV

By decision year
1 clearance under product code OMV with a decision year between 2009 and 2009, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OMV by decision year
YearClearances
20091

Applicants with the most clearances

Product code OMV
Applicants holding the most 510(k) clearances under product code OMV
ApplicantClearances
Intelametrix, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code